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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2017
Event Type  malfunction  
Manufacturer Narrative
A document based investigation evaluation was also performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. The device was returned in an open package. The product was returned with the udh handle and the basket formation in the closed positions. A functional test was performed and the udh handle actuated the basket formation, but the basket formation would not fully expand at the top. Based on the provided information a definitive root cause cannot be established or reported at this time. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
Manufacturer Narrative
(b)(4). Event is currently under investigation. A follow up report will be send upon conclusion.
 
Event Description
It was reported that prior to a ureteroscopy procedure, the wires of the ngage nitinol stone extractor basket were noted to be crossed. This was noted prior to use so a new ngage nitinol stone extractor was opened and used to perform the procedure. There was no adverse event.
 
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Brand NameNGAGE NITINOL STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6409449
MDR Text Key196207793
Report Number1820334-2017-00438
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNGE-022115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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